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FDA Drug Application 015923 by JANSSEN PHARMS

Application Number015923
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/1971N       
AP012/3/1975SFP       
AP012/3/1975SCS       
AP02/13/1978SLR       
AP02/12/1980SLR       
AP010/2/1981SLR       
AP07/6/1979SLR       
AP01/22/1980SCM       
AP01/23/1981SLR       
AP01/23/1981SLR       
AP010/2/1981SLR       
AP06/23/1982SCM       
AP04/20/1981SCM       
AP09/8/1982SLR       
AP01/31/1983SLR       
AP03/11/1983SLR       
AP010/29/1984SCE       
AP04/7/1986SCM       
AP01/30/1987SCM       
AP01/30/1987SCM       
AP04/25/1988SCM       
AP07/27/1988SCM       
AP02/12/1988SCM       
AP03/28/1988SCM       
AP05/2/1988SCM       
AP06/2/1988SCM       
AP08/28/1996SLR       
AP02/14/1990SCS       
AP02/23/1990SCM       
AP06/29/1994SCS       
AP01/30/1995SCM       
AP012/5/1994SCM       
AP04/23/1998SCS       
AP05/10/1996SCM       
AP05/2/2000SLR       
AP01/26/2000SCM       
AP03/16/2000SCM       
AP04/13/2000SCM       
AP011/7/2000SCM       
AP04/17/2002SLR17045072   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/015923_S072_HALDOL_TABLETS_AP.pdf 7/6/2007
AP012/10/2002SCM       
AP05/4/2007SLR16439078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf 5/7/2007
AP05/4/2007SLR16485078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s078, 018701s053ltr.pdf 5/9/2007
AP08/12/2011SLR29782079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s079,018701s054ltr.pdf 8/15/2011
AP08/12/2011SLR29792079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s079lbl.pdf 8/16/2011
AP09/19/2007SLR17942080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s080, 018701s055ltr.pdf 9/25/2007
AP05/13/2008SLR19825081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056ltr.pdf 5/14/2008
AP05/13/2008SLR19945081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf 6/5/2008
AP08/14/2008SLR20619082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s082, 018701s057ltr.pdf 8/19/2008
AP08/14/2008SLR20709082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf 8/29/2008
AP07/19/2009SLR23115084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015923s084,018701s059ltr.pdf 8/4/2009
AP07/19/2009SLR23194084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015923s084lbl.pdf 8/14/2009
AP012/1/2010SLR27187085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/015923s085lbl.pdf 12/4/2010
AP012/1/2010SLR27200085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/015923s085,018701s062ltr.pdf 12/6/2010
AP03/1/2011SLR28086086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf 3/4/2011
AP03/1/2011SLR28094086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063ltr.pdf 3/7/2011
AP05/6/2013SLR35975089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/015923Orig1s089,018701Orig1s065ltr.pdf 5/7/2013
AP05/26/2015SLR42927091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/015923Orig1s091ltr.pdf 5/28/2015
AP05/26/2015SLR42946091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/015923s091lbl.pdf 5/29/2015
AP05/18/2016SLR46071094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015923Orig1s094,018701Orig1s072ltr.pdf 5/20/2016
AP05/18/2016SLR46091094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf 5/20/2016




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